Dataset Open Access

Data from: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: two open-label, randomized, safety trials

Bastiaens, Guido; Tiono, Alfred B.; Okebe, Joseph; Pett, Helmi; Coulibaly, Sam A.; Gonçalves, Bronner P.; Affara, Muna; Ouédraogo, Alphonse; Bougouma, Edith C.; Sanou, Guillaume S.; Nébié, Issa; Bradley, John; Lanke, Kjerstin H. W.; Niemi, Mikko; Sirima, Sodiomon B.; d'Alessandro, Umberto; Bousema, Teun; Drakeley, Chris; Bastiaens, Guido J. H.; Pett, Helmi E.; d'Alessandro, Umberto


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  <identifier identifierType="URL">https://zenodo.org/record/4988492</identifier>
  <creators>
    <creator>
      <creatorName>Bastiaens, Guido</creatorName>
      <givenName>Guido</givenName>
      <familyName>Bastiaens</familyName>
    </creator>
    <creator>
      <creatorName>Tiono, Alfred B.</creatorName>
      <givenName>Alfred B.</givenName>
      <familyName>Tiono</familyName>
    </creator>
    <creator>
      <creatorName>Okebe, Joseph</creatorName>
      <givenName>Joseph</givenName>
      <familyName>Okebe</familyName>
      <affiliation>Medical Research Council</affiliation>
    </creator>
    <creator>
      <creatorName>Pett, Helmi</creatorName>
      <givenName>Helmi</givenName>
      <familyName>Pett</familyName>
    </creator>
    <creator>
      <creatorName>Coulibaly, Sam A.</creatorName>
      <givenName>Sam A.</givenName>
      <familyName>Coulibaly</familyName>
    </creator>
    <creator>
      <creatorName>Gonçalves, Bronner P.</creatorName>
      <givenName>Bronner P.</givenName>
      <familyName>Gonçalves</familyName>
    </creator>
    <creator>
      <creatorName>Affara, Muna</creatorName>
      <givenName>Muna</givenName>
      <familyName>Affara</familyName>
      <affiliation>Medical Research Council</affiliation>
    </creator>
    <creator>
      <creatorName>Ouédraogo, Alphonse</creatorName>
      <givenName>Alphonse</givenName>
      <familyName>Ouédraogo</familyName>
    </creator>
    <creator>
      <creatorName>Bougouma, Edith C.</creatorName>
      <givenName>Edith C.</givenName>
      <familyName>Bougouma</familyName>
    </creator>
    <creator>
      <creatorName>Sanou, Guillaume S.</creatorName>
      <givenName>Guillaume S.</givenName>
      <familyName>Sanou</familyName>
    </creator>
    <creator>
      <creatorName>Nébié, Issa</creatorName>
      <givenName>Issa</givenName>
      <familyName>Nébié</familyName>
    </creator>
    <creator>
      <creatorName>Bradley, John</creatorName>
      <givenName>John</givenName>
      <familyName>Bradley</familyName>
      <affiliation>London School of Hygiene &amp; Tropical Medicine</affiliation>
    </creator>
    <creator>
      <creatorName>Lanke, Kjerstin H. W.</creatorName>
      <givenName>Kjerstin H. W.</givenName>
      <familyName>Lanke</familyName>
      <affiliation>Radboud University Nijmegen</affiliation>
    </creator>
    <creator>
      <creatorName>Niemi, Mikko</creatorName>
      <givenName>Mikko</givenName>
      <familyName>Niemi</familyName>
      <affiliation>University of Helsinki</affiliation>
    </creator>
    <creator>
      <creatorName>Sirima, Sodiomon B.</creatorName>
      <givenName>Sodiomon B.</givenName>
      <familyName>Sirima</familyName>
    </creator>
    <creator>
      <creatorName>d'Alessandro, Umberto</creatorName>
      <givenName>Umberto</givenName>
      <familyName>d'Alessandro</familyName>
    </creator>
    <creator>
      <creatorName>Bousema, Teun</creatorName>
      <givenName>Teun</givenName>
      <familyName>Bousema</familyName>
      <affiliation>Radboud University Nijmegen</affiliation>
    </creator>
    <creator>
      <creatorName>Drakeley, Chris</creatorName>
      <givenName>Chris</givenName>
      <familyName>Drakeley</familyName>
    </creator>
    <creator>
      <creatorName>Bastiaens, Guido J. H.</creatorName>
      <givenName>Guido J. H.</givenName>
      <familyName>Bastiaens</familyName>
      <affiliation>Radboud University Nijmegen</affiliation>
    </creator>
    <creator>
      <creatorName>Pett, Helmi E.</creatorName>
      <givenName>Helmi E.</givenName>
      <familyName>Pett</familyName>
      <affiliation>University of Helsinki</affiliation>
    </creator>
    <creator>
      <creatorName>d'Alessandro, Umberto</creatorName>
      <givenName>Umberto</givenName>
      <familyName>d'Alessandro</familyName>
      <affiliation>Medical Research Council</affiliation>
    </creator>
  </creators>
  <titles>
    <title>Data from: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: two open-label, randomized, safety trials</title>
  </titles>
  <publisher>Zenodo</publisher>
  <publicationYear>2018</publicationYear>
  <subjects>
    <subject>Plasmodium falciparum</subject>
    <subject>haemoglobin</subject>
    <subject>primaquine</subject>
    <subject>haemolysis</subject>
    <subject>safety</subject>
    <subject>gametocyte</subject>
    <subject>reticulocytes</subject>
    <subject>malaria</subject>
  </subjects>
  <dates>
    <date dateType="Issued">2018-12-18</date>
  </dates>
  <resourceType resourceTypeGeneral="Dataset"/>
  <alternateIdentifiers>
    <alternateIdentifier alternateIdentifierType="url">https://zenodo.org/record/4988492</alternateIdentifier>
  </alternateIdentifiers>
  <relatedIdentifiers>
    <relatedIdentifier relatedIdentifierType="DOI" relationType="IsCitedBy">10.1371/journal.pone.0190272</relatedIdentifier>
    <relatedIdentifier relatedIdentifierType="DOI" relationType="IsIdenticalTo">10.5061/dryad.230ps</relatedIdentifier>
    <relatedIdentifier relatedIdentifierType="URL" relationType="IsPartOf">https://zenodo.org/communities/dryad</relatedIdentifier>
  </relatedIdentifiers>
  <rightsList>
    <rights rightsURI="https://creativecommons.org/publicdomain/zero/1.0/legalcode">Creative Commons Zero v1.0 Universal</rights>
    <rights rightsURI="info:eu-repo/semantics/openAccess">Open Access</rights>
  </rightsList>
  <descriptions>
    <description descriptionType="Abstract">Background: Primaquine (PQ) actively clears mature Plasmodium falciparum gametocytes but in glucose-6-phosphate dehydrogenase deficient (G6PDd) individuals can cause hemolysis. We assessed the safety of low-dose PQ in combination with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) in G6PDd African males with asymptomatic P. falciparum malaria.  Methods and findings: In Burkina Faso, G6PDd adult males were randomized to treatment with AL alone (n = 10) or with PQ at 0.25 (n = 20) or 0.40 mg/kg (n = 20) dosage; G6PD-normal males received AL plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. In The Gambia, G6PDd adult males and boys received DP alone (n = 10) or with 0.25 mg/kg PQ (n = 20); G6PD-normal males received DP plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. The primary study endpoint was change in hemoglobin concentration during the 28-day follow-up. Cytochrome P-450 isoenzyme 2D6 (CYP2D6) metabolizer status, gametocyte carriage, haptoglobin, lactate dehydrogenase levels and reticulocyte counts were also determined. In Burkina Faso, the mean maximum absolute change in hemoglobin was -2.13 g/dL (95% confidence interval [CI], -2.78, -1.49) in G6PDd individuals randomized to 0.25 PQ mg/kg and -2.29 g/dL (95% CI, -2.79, -1.79) in those receiving 0.40 PQ mg/kg. In The Gambia, the mean maximum absolute change in hemoglobin concentration was -1.83 g/dL (95% CI, -2.19, -1.47) in G6PDd individuals receiving 0.25 PQ mg/kg. After adjustment for baseline concentrations, hemoglobin reductions in G6PDd individuals in Burkina Faso were more pronounced compared to those in G6PD-normal individuals receiving the same PQ doses (P = 0.062 and P = 0.022, respectively). Hemoglobin levels normalized during follow-up. Abnormal haptoglobin and lactate dehydrogenase levels provided additional evidence of mild transient hemolysis post-PQ.  Conclusions: Single low-dose PQ in combination with AL and DP was associated with mild and transient reductions in hemoglobin. None of the study participants developed moderate or severe anemia; there were no severe adverse events. This indicates that single low-dose PQ is safe in G6PDd African males when used with artemisinin-based combination therapy.</description>
    <description descriptionType="Other">&lt;div class="o-metadata__file-usage-entry"&gt;SAFEPRIM Burkina Faso Adverse Events&lt;div class="o-metadata__file-description"&gt;Adverse events SAFEPRIM trial Burkina Faso&lt;/div&gt;&lt;div class="o-metadata__file-name"&gt;DRYAD_SAFEPRIM Burkina Faso Adverse Events.xlsx&lt;br&gt;&lt;/div&gt;&lt;/div&gt;&lt;div class="o-metadata__file-usage-entry"&gt;SAFEPRIM Gambia Adverse Events&lt;div class="o-metadata__file-description"&gt;Adverse events SAFEPRIM trial The Gambia&lt;/div&gt;&lt;div class="o-metadata__file-name"&gt;DRYAD_SAFEPRIM Gambia Adverse Events.xlsx&lt;br&gt;&lt;/div&gt;&lt;/div&gt;&lt;div class="o-metadata__file-usage-entry"&gt;DRYAD SAFEPRIM main dataset Burkina Faso&lt;div class="o-metadata__file-description"&gt;Laboratory results from clinical trial in Burkina Faso. Data include haemoglobin concentration, reticulocyte counts, full haematology and biochemistry.&lt;/div&gt;&lt;div class="o-metadata__file-name"&gt;&lt;/div&gt;&lt;/div&gt;&lt;div class="o-metadata__file-usage-entry"&gt;DRYAD SAFEPRIM main dataset The Gambia&lt;div class="o-metadata__file-description"&gt;Laboratory results from clinical trial in The Gambia. Data include haemoglobin concentration, reticulocyte counts, full haematology and biochemistry.&lt;/div&gt;&lt;div class="o-metadata__file-name"&gt;&lt;/div&gt;&lt;/div&gt;&lt;p&gt;Funding provided by: National Science Foundation&lt;br&gt;Crossref Funder Registry ID: http://dx.doi.org/10.13039/100000001&lt;br&gt;Award Number: BMGF OPP1034789&lt;/p&gt;</description>
  </descriptions>
  <geoLocations>
    <geoLocation>
      <geoLocationPlace>The Gambia</geoLocationPlace>
    </geoLocation>
    <geoLocation>
      <geoLocationPlace>Burkina Faso</geoLocationPlace>
    </geoLocation>
  </geoLocations>
</resource>
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